Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT07232095
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 to 70 years, regardless of sex.
2. Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.
3. Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.
4. No prior H. pylori eradication therapy.
5. Written informed consent before participation.
Exclusion Criteria:
1. Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).
2. Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.
3. Pregnant or lactating women.
4. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.
5. Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.
6. History of gastric or esophageal surgery.
7. Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07232095
Study Brief:
Protocol Section:
NCT07232095